FDA 510(k) Decisions During March, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
DEN170046 03/06/2018 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) 23andMe, Inc. Lisa Charter
K173437 03/19/2018 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H 3M Company Hilary B. Hovde
K180404 03/16/2018 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System 3M Health Care Lam Duong
K173628 03/10/2018 Acclarent ENT Navigation System Acclarent, Inc James Patrick Garvey
K180504 03/28/2018 Mission Lipid Panel Monitoring System ACON Laboratories, Inc. Qiyi Xie
K180196 03/07/2018 On Call Express Mobile Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K173310 03/26/2018 SmartTouch Adherium (NZ) Ltd Chris Mander
K172799 03/09/2018 Positional Sleep Assessment System (PoSAS) software Advanced Brain Monitoring Daniela Soll
K173223 03/02/2018 ologen Collagen Matrix Aeon Astron Europe B.V. Horng Ji Lai
K172235 03/28/2018 CoreHip« System Aesculap Implants Systems, LLC Paul Amudala
K180321 03/07/2018 Aesculap Optilene Nonabsorbable Suture Aesculap, Inc. Kathy A. Racosky
K172461 03/23/2018 AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin Aesku.Diagnostics GmbH & Co. KG Sandra Reuter
K173660 03/27/2018 LenSx Laser System Alcon Laboratories, Inc. James Arganda
K173128 03/22/2018 Alamo« C Alliance Partners, LLC Kristiina Gilkey
K170957 03/20/2018 ReConnex Pre-Sutured Tendon AlloSource Pamela Vetter
K173727 03/28/2018 Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor Ambu A/S Maja Brons
K173453 03/05/2018 Valeo« C+CSC with Lumen Interbody Fusion Device Amedica Corp. Jason Parberry
K171857 03/30/2018 AMSure« Enteral Feeding Syringe with ENFit Tip Amsino International, Inc. Cathy Hong
K171863 03/19/2018 Anjon Bremer Halo System Anjon Holdings, LLC Tommy Mitchell
K173788 03/01/2018 Arthrex Corkscrew FT Arthrex Inc. David L Rogers
K171841 03/29/2018 Arthrex Shoulder System Arthrex Inc. David L. Rogers
K172371 03/22/2018 Arthrex UNIVERS REVERS COATED BASEPLATE Arthrex, Inc. Courtney Smith
K170304 03/02/2018 Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers Astell Scientific Limited Gary Doughty
K173203 03/14/2018 Athena GTX Device Management Suite (ADMS) Software Athena GTX Sean Mahoney
K173760 03/22/2018 Monarch Endoscopy Platform (Monarch Platform) Auris Surgical Robotics, Inc. Joy Sacmar
K180061 03/09/2018 UltraCor Twirl Breast Tissue Marker Bard Peripheral Vascular, Inc. Meghan McKelvey
K180319 03/27/2018 Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution Bausch and Lomb Incorporated Melissa Thomas
K171802 03/07/2018 ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) Bayer HealthCare LLC Cindy R. Abraham
K180438 03/20/2018 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit BD Brad Spring
K173873 03/16/2018 BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial Becton Dickinson and Company Ashanti Brown
K172366 03/16/2018 Wrist Pulse Oximeter Beijing Choice Electronic Technology Co., Ltd. Lei Chen
DEN160029 03/01/2018 SkinPen Precision System BELLUS MEDICAL, LLC. JENNIFER BLOCK
K173682 03/09/2018 L300 Go System Bioness, Inc. Mercedes Bayani
K180315 03/26/2018 DISKOM Biopsybell s.r.l. Tiziana Bellini
K171851 03/16/2018 SOFTXIL BISTOOL Eunhyun Bae
K173180 03/15/2018 Mega Plus Spine System BK MEDITECH Co., Ltd. Byoungjun Park
K172843 03/29/2018 TwitchView System Blink Device Corporation Justin Hulvershorn
K180211 03/21/2018 Freezpoint Bovie Medical Corp. Sam Niedbala
K172820 03/01/2018 Microscope Navigation Software Brainlab AG Alexander Schwiersch
K172035 03/24/2018 EKOS ultrasound EVD Device, EVD Control Unit BTG International, Inc. Brit Baird
K173839 03/15/2018 Tissue of Origin Test Kit-FFPE Cancer Genetics, Inc. Janet Graff
K180323 03/30/2018 Vitrea Software Package; VSTP-001A Canon Medical Systems Corporation Paul Biggins
K180475 03/19/2018 CapLOX II« / TowerLOX« MIS Pedicle Screw System Captiva Spine, Inc. Jackie Ferro
K173812 03/09/2018 Catalyst CSR 3 Peg Glenoids Catalyst OrthoScience, Inc Dale Davison
K173904 03/09/2018 CATS Tonometer Prism CATS Tonometer, LLC Sean J. McCafferty
K180274 03/21/2018 Ventix Link Knotless Anchor with Inserter Cayenne Medical, Inc Shima Hashemian
K173942 03/05/2018 Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Central Medicare Sdn. Bhd. Arivalagan Subramaniam
K173840 03/16/2018 Xpert CT/NG Cepheid Yi-Ping Lin
K180531 03/29/2018 NovoStitch Pro Meniscal Repair System Ceterix Orthopaedics, Inc. Tarhan Kayihan
K180104 03/14/2018 Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant Church & Dwight Co., Inc Joelle Reinson
K180057 03/09/2018 VORTEK URETERAL DOUBLE LOOP STENT Coloplast Corp Cori Ragan
K172516 03/16/2018 SurgiQuest AIRSEAL iFS System ConMed Corporation Lisa Anderson
K171817 03/13/2018 Biodesign Diaphragmatic Hernia Graft Cook Biotech Incorporated Perry W. Guinn
K172017 03/26/2018 Black Silicone Filiform Double Pigtail Stent Set Cook Incorporated Karthik Pillai
K171810 03/07/2018 Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter Cook Incorporated Yan Li
K171912 03/19/2018 Double Flexible Tip Wire Guides Cook Incorporated Jennifer Allman
K173105 03/22/2018 Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter Cook Incorporated Samuel Engelman
K171764 03/09/2018 Fixed Core Wire Guides Cook Incorporated Jennifer Allman
K171997 03/30/2018 Mandril Wire Guide Cook Incorporated Jennifer Allman
K171915 03/01/2018 Nathanson Transcystic Bile Duct Stone Exploration Pack Cook Incorporated Colin Jacob
K171988 03/30/2018 Performer Guiding Sheath Cook Incorporated Reuben G. Lidster
K171820 03/09/2018 Transjugular Liver Access Sets Cook Incorporated David Lehr
K172057 03/09/2018 Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set Cook Ireland Ltd. Orla Gunning
K173731 03/02/2018 SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) CooperSurgical, Inc Tove Kjaer
K180429 03/14/2018 Advincula Delineator Uterine Manipulator CooperSurgical, Inc. Roaida Johnson
K180052 03/23/2018 UriSwab-Urine Collection, Transport and Preservation System Copan Italia S.p.A. Elisabetta Zanella
K173806 03/01/2018 CorPath GRX System Corindus, Inc. Robert Lavado
K180517 03/29/2018 CorPath GRX System Corindus, Inc. Robert Lavado
K173281 03/02/2018 LigaSure Exact Dissector, Nano-coated Covidien Celso Duran
K180192 03/21/2018 Emprint Ablation Visualization Application Covidien, LLC Patti L. Arndt
K180149 03/26/2018 Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide Covidien, llc Nancy Sauer
K173922 03/26/2018 C-PTFETM Surgical Suture CP Medical Inc. John Hartigan
K172601 03/02/2018 Next Generation iBOT DEKA Research & Development Corp Roger Leroux
K172256 03/02/2018 SoftVue Delphinus Medical Technologies Francis X. Dobscha
K173465 03/28/2018 Concentrix MX-AC High-Speed Handpiece DentalEZ, Inc. Dan Laskowitz
K180044 03/08/2018 SIROLaser Blue Dentsply Sirona Karl J Nittinger
K172872 03/05/2018 DePuy Synthes Femoral Neck System DePuy Synthes Ana Sala Roca
K173785 03/13/2018 Custom Clear Aligner System Derby Dental Laboratory Reed Nunnally
K173846 03/21/2018 DermaScalp Laser Cap DermaScalp LLC John Carullo
K172648 03/23/2018 Drive DeVilbiss iGo 2 Portable Oxygen Concentrator DeVilbiss Healthcare, LLC Betty Miller
DEN170088 03/27/2018 Dexcom G6 Continuous Glucose Monitoring System Dexcom, Inc. Neeta Sharma
K173798 03/14/2018 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack DiaSorin Molecular LLC Sharon Young
K180074 03/22/2018 Diazyme Lipoprotein (a) Assay Diazyme Laboratories, Inc. Abhijit Datta
K172381 03/06/2018 Digitimer DS7AP Constant Current Stimulator Digitimer Ltd. John Smale
K171750 03/06/2018 Citric Complete Dry Citric Acid (45X) Dimesol USA, LLC Marlene Van Dyke
K171952 03/30/2018 Dimesol Tubing Sets for Hemodialysis Dimesol, Inc. Stephen P. Callaghan
K170608 03/30/2018 UF(II) Implant System DIO Corporation Jiae Park
K173769 03/08/2018 DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid DMAX CO., LTD. Hyeon Seok Cho
K172891 03/16/2018 Infrared Thermometer Dongguan HCS Electronics Co., Ltd Angel You
K180350 03/07/2018 Dornier Medilas H Solvo 35 Laser Dornier MedTech America John Hoffer
K180106 03/13/2018 ThinkQA DOSIsoft Marc Uszynski
K171542 03/16/2018 TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges Dr. Harold Katz, LLC (dba TheraBreath Harold Katz
K173075 03/08/2018 ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850?l, 3ml) DxNow, Inc. William T. Sharp
K172266 03/14/2018 Dynarex Three-Way Stopcock Dynarex Corporation Pablo Martinez
K180473 03/23/2018 ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR ECOTRON Co., Ltd Sang Bond Lee
DEN160044 03/16/2018 Acumen Hypotension Prediction Index (HPI) Feature Software Edwards Lifesciences LLC Lisa Gilman
K172312 03/30/2018 eego amplifiers eemagine Medical Imaging Solutions GmbH Frank Zanow
K180538 03/30/2018 gammaCore Sapphire electroCore, LLC Mike Romaniw
K173789 03/30/2018 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon Elekta Instrument AB Alf Laurell
K180224 03/15/2018 ELEMENT-TL Elemenic Co., Ltd. Jo Won Ju
K180406 03/15/2018 Ellipse Ydun Ellipse A/S Ole Kofod
K180165 03/20/2018 Habib EndoHPB EMcision Ltd. Francois Poulin
K173723 03/05/2018 EMPOWR Universal Tibial Baseplate Encore Medical, L.P. Teffany Hutto
K180592 03/30/2018 G-scan Brio Esaote S.p.A Massimo Polignano
K173388 03/09/2018 Exactech Equinoxe Stemless Shoulder Exactech Inc Thomas McNamara
K173583 03/12/2018 Exactech« Novation« and AcuMatch« E-HXL Acetabular Liners Exactech, Inc. Shing Jen Tai
K173777 03/08/2018 BreathID Hp Lab System Exalenz Bioscience Ltd. Raffi Werner
K173772 03/08/2018 BreathID Hp System Exalenz Bioscience Ltd. Raffi Werner
K173439 03/29/2018 Bloom2 Programmable Electrophysiology Stimulator Fischer Medical Wes Rogers
K180405 03/15/2018 FUJIFILM Endoscope Models EC-600HL and EC-600LS FUJIFILM Corporation Randy Vader
K172916 03/01/2018 FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 Fujifilm Corporation Randy Vader
K173494 03/06/2018 OrthoSteady G Bone Cement G21 s.r.l. Filippo Foroni
K180023 03/21/2018 WIRION Gardia Medical Ltd. Vardit Segal
K180092 03/08/2018 Intellitorq Gauthier Biomedical, Inc. Austin Braganza
K173500 03/08/2018 NMF004A GC America Inc. Mark Heiss
K180535 03/29/2018 Voluson P6 and Voluson P8 GE Healthcare Bryan Behn
K180374 03/13/2018 Voluson S8/ Voluson S10/ Voluson S10 Expert GE Healthcare Bryan Behn
K180056 03/28/2018 Genesys Spine AIS-C Cervical Anchored Interbody System Genesys Spine Benjamin V. Keller
K180579 03/19/2018 Ezee Retrieval Genicon, Inc Katlyn Kachman
K172810 03/07/2018 PORT-X IV GENORAY Co., Ltd. Ji-Yeon Choi
K172103 03/02/2018 Flowtron DVT5 Small Calf Garment Getinge (Suzhou) Co., Ltd. Daisy Qin
K180171 03/08/2018 PillCam Patency System Given Imaging Ltd. Hilla Debby
K180156 03/07/2018 SP-Fix« Spinous Process Fixation Plate, RELIEVE« Laminoplasty Fixation System Globus Medical Inc. Lori Burns
K171939 03/07/2018 ALVUE Balloon Dilation System Globus Medical, Inc. Lori Burns
K172269 03/27/2018 FORTRESSÖ Radiopaque Bone Cement (FORTRESSÖ and FORTRESS-PlusÖ), CREO« Fenestrated Screw System, REVLOK« Fenestrated Screw System Globus Medical, Inc. Kelly J. Baker
K171867 03/30/2018 DrÆs Finder NEO Good Doctors Co.,Ltd. Sungro Joo
K173229 03/12/2018 Preview Digital Pregnancy Test Guangzhou Wondfo Biotech Co., Ltd. Bin Chen
K180086 03/08/2018 Gyrus ACMI û EZDilate 3-Stage Balloon Dilatation Catheter Gyrus ACMI, Inc. Mary Anne Patella
K173903 03/22/2018 Granada Medium Hardy Diagnostics Rianna Malherbe
K173312 03/02/2018 ProBx Software Harmonus Inc. Nicole Mauro
K172168 03/21/2018 WillCeph HDX WILL CORP. Myoung-Joon Lee
K172892 03/08/2018 Neuro Assessment System NAS-1000 HeadSense Medical Inc. Richard A. Lotti
K171982 03/21/2018 DROPLET PEN NEEDLE HTL-STREFA S.A. Aleksandra Prazmowska-Wilanowska
K173919 03/20/2018 HX Device Human Extension Ltd. Dalit Doron
K171241 03/27/2018 Pulse Oximeter Hunan Accurate Bio-Medical Technology Co., Ltd. Zhou Le
K180326 03/08/2018 icobrain icometrix Dirk Smeets
K180129 03/16/2018 Imbio Segmentation Editing Tool software Imbio, LLC Vipul Goel
K172078 03/30/2018 ImmuLisa Enhanced RNA POL III Antibody ELISA IMMCO Diagnostics, Inc. Kevin Lawson
K173811 03/15/2018 TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System In2Bones SAS Morgane Grenier
K173571 03/21/2018 Element System with IBT Electrodes Infinite Biomedical Technologies, LLC Rahul Kaliki
K173120 03/16/2018 CCM Abutment System InnoBioSurg Co., Ltd. Bo-reum Yoo
K173262 03/06/2018 Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter Innovative Health, Llc. Amy Stoklas-Oakes
K172760 03/26/2018 REST EAZY Appliance Insert Molding Solutions, Inc. Paul Hendrixson
K173379 03/30/2018 Straumann Variobase for Crown AS Institut Straumann AG Gordon Dodds
K180486 03/22/2018 HemosIL Factor XII Deficient Plasma Instrumentation Laboratory Co. Carol Marble
K171778 03/14/2018 MR Wireless Gating System, Model WGS-100 Ivy Biomedical Systems, Inc Nicole Bush
K170605 03/27/2018 Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D Jiangsu Yuyue Medical Equipment& Supply Co., Ltd Rong Zhong
K172264 03/19/2018 OTW Takeru PTCA Balloon Dilatation Catheter Kaneka Corporation Toshihiko Motomine
K173426 03/09/2018 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System KCI USA, INC. Margaret Marsh
K173447 03/02/2018 V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit KCI USA, Inc. Melanie Avila
K172723 03/23/2018 Dario LC Blood Glucose Monitoring System LabStyle Innovation, Ltd. Erez Raphael
K173886 03/23/2018 CPRmeter 2 CPR Feedback Device Laerdal Medical AS Mari Kaada
K172818 03/07/2018 LMT-3000 Lameditech Co., Ltd. Jong Seuk Choi
K173323 03/08/2018 AnastoClip GC Closure System LeMaitre Vascular, Inc. Xiang Zhang
K173346 03/02/2018 LENSAR Laser System - fs 3D (LLS-fs 3D) Lensar, Inc. Keith Peck
K172331 03/02/2018 Type I, Type II, Type III, Type IV Lepu Medical Technology (Beijing) Co., Ltd. Xiangdan Jin
K180114 03/27/2018 AEON Retrieval Bag Lexington Medical Inc. Donna Gasper
K180330 03/15/2018 Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL Liofilchem s. r. l. Fabio Brocco
K170410 03/23/2018 Longeviti PMMA Static Cranial Implant Longeviti Neuro Solutions, LLC Kevin Lee
DEN170029 03/19/2018 PrimeStore MTM Longhorn Vaccines and Diagnostics LLC Jeff Fischer
K173619 03/21/2018 Mimics inPrint Materialise NV Oliver Clemens
K171129 03/02/2018 CO Check Pro, CO Screen MD Diagnostics Limited Glen Hillsley
K173794 03/14/2018 AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared Medacta International SA Stefano Baj
K171966 03/27/2018 Mpact« 3D MetalÖ Implants and Augments 3D MetalÖ Medacta International SA Stefano Baj
K180308 03/27/2018 Prelude MedCom GmbH Johannes Messow
K173605 03/08/2018 iQMR Medic Vision - Imaging Solutions Ltd Eyal Aharon
K173134 03/22/2018 SENTIO MMG Pedicle Access Needles Medos International SARL Sheree Geller
K172062 03/05/2018 AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray MedScience Science Research Group, Inc. Marvin Smollar
K172444 03/28/2018 ROSA BRAIN (v3.0.0.5) MEDTECH S.A. Elise Lagacherie
K180453 03/22/2018 Bio-Medicus Adult Cannulae and Introducer Medtronic Inc Huda Yusuf
K180456 03/22/2018 Bio-Medicus Adult Cannulae Kit Medtronic Inc. Huda Yusuf
K173249 03/08/2018 CD HORIZONÖ Spinal System Medtronic Sofamor Danek USA, Inc. Ankit K. Shah
K171320 03/08/2018 ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, AR Meril Healthcare Pvt. Ltd. Umesh Sharma
K180450 03/12/2018 Corvocet Biopsy System Merit Medical Systems, Inc. Angela Brady
K173548 03/30/2018 Merit Pursue Microcatheter Merit Medical Systems, Inc. Niloufar Samimi
K172663 03/05/2018 Cytology Brush Micro-Tech (Nanjing) CO., Ltd. Becky Li
K171937 03/16/2018 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K171150 03/08/2018 AW-100 Micron Corporation Takashi Terui
K180396 03/15/2018 miraDry System Miramar Labs, Inc. Cynthia Kada
K173326 03/16/2018 MIS CONNECT Conical Connection Abutment MIS Implants Technologies LTD. Noa Ofer
K180393 03/15/2018 AIRO Computed Tomography (CT) X-ray System Mobius Imaging, LLC Norma LeMay
K173544 03/02/2018 Phoenix Wound Matrix Nanofiber Solutions, Inc. Ronald L. Bracken
K173690 03/09/2018 Grass TWin Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Shane Sawall
K180421 03/14/2018 Natus NeuroWorks Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Shane Sawall
K173082 03/29/2018 ArcoÖ-SA Lumbar Cage System NeuroStructures, Inc. Kathleen Wong
K180431 03/22/2018 Cortina [MAX] Lumbar Cage System NeuroStructures, Inc. Kathleen Wong
K172485 03/02/2018 Footmotion HammerToe Newclip Technics Gaelle Lussori
K173980 03/14/2018 Specular Microscope CEM-530 Nidek Co., Ltd. Yoneji Mizuno
K173029 03/30/2018 Nipro Syringe Nipro Medical Corporation Jessica Oswald-McLeod
K173214 03/27/2018 NES Reprocessed RF Stylet (RFS) Northeast Scientific, Inc. (NES) Matthew Farley
K180198 03/15/2018 NuVasive« VuePoint« II OCT System NuVasive, Incorporated Michelle Cheung
K173459 03/13/2018 Olympus Small Intestinal Capsule Endoscope System Olympus Medical Systems Corp. Toshiyuki Nakajima
K172298 03/29/2018 OLYMPUS URF-P6/P6R Olympus Medical Systems Corp. Toshiyuki Nakajima
K172246 03/30/2018 OLYMPUS URF-V2/V2R Olympus Medical Systems Corp. Toshiyuki Nakajima
K173680 03/01/2018 Sapphire II PRO OrbusNeich Medical Trading Inc. John Pazienza
K173624 03/02/2018 ORIGIO« HandlingÖ without phenol red (Cat. No. 8310), ORIGIO« HandlingÖ with phenol red (Cat. No. 8311) Origio a/s Tove Kjaer
K173440 03/08/2018 Carriere SLX 3D Clear Ortho Organizers, Inc. Colleen Boswell
K172115 03/08/2018 Navigated Instrument System Orthofix Inc. Jacki Koch
K180109 03/01/2018 STARband, STARlight, St. Louis Band Orthomerica Products, Inc David C. Kerr
K172354 03/26/2018 OssBuilder System Osstem Implant Co., Ltd.. Jungmin Yoo
K162366 03/02/2018 Omega VL OV WORLD CO., LTD GEUNG-GYU GANG
K171703 03/01/2018 PUMA System Panther Orthopedics, Inc. Kathryn Stecco
K171715 03/05/2018 HammerTube System Paragon 28 Frank S. Bono
K180172 03/16/2018 FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroP Paragon Vision Sciences Rich Jefferies
K180194 03/30/2018 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System Paragonix Technologies, Inc. Leo Basta
K180105 03/08/2018 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister Penumbra, Inc. Richard Kimura
K173114 03/07/2018 primeMidline Catheters PFM Medical, Inc. Jessica Jho
K173792 03/13/2018 EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay Phadia AB Carina Magnusson
K173704 03/02/2018 ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip Phadia AB Carina Magnusson
K180195 03/16/2018 Frigitronics adapter Phakos Olivier Aumaitre
K180015 03/20/2018 Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd. Gordon Shu
K173451 03/20/2018 Ingenia Elition S and Ingenia Elition X Philips Medical Systems Nederland B.V. Jan van de Kerkhof
K173356 03/06/2018 Ingenia Elition S and Ingenia Elition X R5.4 Philips Medical Systems Nederland B.V. Jan van de Kerkhof
K172431 03/14/2018 Cardiovascular Analzyer PhysioWave, Inc. Laurent Giovangrandi
K173241 03/23/2018 MED-TAB PLUM Medical Solutions GmbH Arpad Bischof
K173533 03/29/2018 Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter Poiesis Medical, LLC Greg Wiita
K173734 03/12/2018 RocaJJ Soft Stents Promepla SAM Alexandre Bareille
K180426 03/16/2018 Empower H35 Quanta System Spa Francesco Dell'Antonio
K180423 03/15/2018 Empower H65 quanta system spa Francesco Dell'Antonio
K180265 03/02/2018 COMPACT TOUCH Ophthalmic Ultrasound System Quantel Medical Maureen O'Connell
K173939 03/09/2018 Quantib Brain Quantib BV Floor van Leeuwen
K163661 03/21/2018 P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil RAPID Biomedical GmbH Christian Zimmermann
K173741 03/05/2018 Reprocessed ArthoCare Ablation Wand ReNovo, Inc. Mark K. Wells
K173740 03/19/2018 Reprocessed DePuy Mitek Ablation Wand ReNovo, Inc. Mark K. Wells
K173181 03/16/2018 ExSpiron 1Xi Respiratory Motion Inc. Susan Hamann
K173358 03/16/2018 ARTAS System Restoration Robotics, Inc. Raymond Lee
K171655 03/02/2018 cobas m 511 integrated hematology analyzer Roche Diagnostics Hematology, Inc. Dan Bracco
K173887 03/21/2018 cobas CT/NG for use on cobas 6800/8800 systems Roche Molecular Systems, Inc. Nobuko Nakajima
K172928 03/16/2018 Portable X-ray System Rolence Enterprise Inc. Sterling Cheng
K170753 03/23/2018 Acculoc Total Knee System RootLoc Co., Ltd. Jungsun Ha
K172627 03/28/2018 David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette Runbio BioTech Co.,Ltd Chandler Chen
K173713 03/08/2018 HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Ji Yea Lee
DEN170023 03/26/2018 ThermoNeuroModulation Device, TNM Device Scion NeuroStim, LLC Robert Black
K180148 03/21/2018 ATS Thermal Imaging Probe, ATS Patient Interface Unit Securus Medical Group, Inc. William J. Gorman
K173425 03/23/2018 SRT-100+ Sensus Healthcare, Inc. Nicolas Soro
K180335 03/08/2018 Accutension Smartphone Auscultatory Blood Shanghai Hulu Devices Co., Ltd Junfeng Zhao
K172135 03/02/2018 uCT Computed Tomography X-ray System Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K171214 03/02/2018 Infrared Thermometer Shenzhen Brav Electronic Technologies Co., Ltd. Aaron Wan
K171430 03/15/2018 Incontinence Treatment Device, Model LT2061 Shenzhen Dongdixin Technology Co., Ltd Truman Shen
K172972 03/02/2018 Wrist Type Automatic Blood Pressure Monitor Shenzhen Jiacom Technology Co., Ltd Luo Tianfeng
K172795 03/14/2018 Infrared Thermometer Shenzhen Jumper Medical Equipment Co., Ltd. Rambo Yang
K180016 03/20/2018 Home Use IPL Beauty Device Shenzhen Mismon Technology Co., Ltd Vicky Yang
K173517 03/30/2018 RADspeed fit SHIMADZU corporation Toshio Kadowaki
K180262 03/12/2018 SICAT Endo SICAT GmbH & Co. KG Manfred Breuer
K172322 03/29/2018 Atellica IM Total hCG (ThCG) Siemens Healthcare Diagnostics Inc. Anoop Joy
K173617 03/30/2018 MAGNETOM Vida with Compressed Sensing GRASP-VIBE Siemens Medical Solutions USA, Inc. Cordell L. Fields
K173607 03/21/2018 SOMATOM Edge Plus Siemens Medical Solutions USA, Inc. Alaine Medio
K173630 03/30/2018 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173625 03/08/2018 syngo.CT Clinical Extensions Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173637 03/30/2018 syngo.CT Coronary Analysis; syngo.CT Vascular Analysis Siemens Medical Solutions USA, Inc. Kimberly Mangum
K173408 03/21/2018 Mammomat Revelation Siemens Medical Solutions, Inc. Denise Adams
K173611 03/16/2018 syngo Application Software Siemens Medical Solutions, USA Inc. Patricia D. Jones
K173779 03/12/2018 REXMONO, PDREX SM ENG CO., LTD Soon-Gu Lee
K180334 03/05/2018 LEGION Knee System Smith & Nephew, Inc. Michael Scott
K172335 03/30/2018 Bleep DreamPort snapCPAP Stuart Heatherington
K173796 03/09/2018 Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) Sofradim Production Benjamin Rochette
K180443 03/22/2018 Tumark Vision SOMATEX Medical Technologies GmbH Burkhard Jakob
K180448 03/15/2018 INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter Sorin Group Italia S.r.l Luigi Vecchi
K180411 03/16/2018 MEMO 4D Sorin Group Italia S.r.l. Mauro Ercolani
K173591 03/28/2018 Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas Spectrum Medical Ltd Mark Drain
K180558 03/28/2018 PressureWire X St. Jude Medical (now part of Abbott Medical) Josh Johnson
K172012 03/14/2018 star RF Electrode, VIVA RF Electrode STARmed Co., Ltd. Jun-Young Jung
K172593 03/16/2018 XCelliStem Wound Powder StemSys Clay Fette
K173481 03/09/2018 Amsco Evolution Medium Steam Sterilizer STERIS Corporation Anthony Piotrkowski
K173488 03/01/2018 CELERITY 20 HP Challenge Pack STERIS Corporation Anthony Piotrkowski
K173256 03/02/2018 System 1 endo Liquid Chemical Sterilant Processing System Steris Corporation Marcia L Benedict
K173428 03/02/2018 VERIFY Chemical Indicator for S40 Sterilant STERIS Corporation Marcia L. Benedict
K173841 03/18/2018 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm Stryker Angelica Beckmann
K172148 03/19/2018 Anchorage Bone Plating System Stryker GmbH Jackie Perri
K173499 03/19/2018 Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads Stryker Orthopaedics Kirsten Lehmuller
K171624 03/29/2018 IXOS Radius Plate System Stuckenbrock Medizintechnik GmbH Fabian Stuckenbrock
K173237 03/19/2018 Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist Syendgen, Inc. Shenda Baker
K180394 03/09/2018 BrightMatter Plan 1.6.0 Synaptive Medical Inc. Maham Ansari
K171808 03/15/2018 TDM Plate and Screw System TDM Co. Ltd. Babu Periasamy
K172590 03/02/2018 Spectra Optia Apheresis System Terumo BCT, Inc. Nicholas Wong
K172071 03/29/2018 Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation) Terumo Cardiovascular Systems Corporation Garry A. Courtney
K173799 03/29/2018 NaviCross 0.018 Terumo Corporation Yuko Watanabe
K180135 03/08/2018 THD Anopress with THD SensyProbe THD SpA Maurizio Pantaleoni
K180063 03/27/2018 OCM-G1 Attachment The Anspach Effort, Inc. Tamara J West
K173915 03/22/2018 Test of Variables of Attention (T.O.V.A.) The TOVA Company Chris Holder
K172267 03/06/2018 IRENE Thoracolumbar Fixation System Tianjin Zhengtian Medical Instrument Co.,Ltd. Ou Changli
K172496 03/23/2018 SUPERCATH 5 (26G) TOGO Medikit Co., Ltd. Daisuke Nagamizu
K180159 03/09/2018 Klassic« Knee System Total Joint Orthopedics, Inc. Chris Weaber
K173930 03/19/2018 PYTHON Plate Trial Instruments Treace Medical Concepts, Inc. Rachel Osbeck
K173694 03/13/2018 STERIZONE VP4 Sterilizer TSO3, Inc. Alexandre Jokci
K173879 03/05/2018 MiniMed Mio Advance infusion set Unomedical A/S Heidi Bjerre Lovkvist
K172611 03/21/2018 Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths Varian Medical Systems, Inc Peter J. Coronado
K173489 03/28/2018 GYN-Pump PH304 W.O.M. World of Medicine GmbH Soeren Markworth
K171989 03/20/2018 Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber R Wilson-Cook Medical Inc. Ashley Howard
K171973 03/21/2018 Captura« Disposable Hot Biopsy Forceps Wilson-Cook Medical, Inc. Ashley Howard
K171969 03/28/2018 Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Ext Wilson-Cook Medical, Inc. Ashley Howard
K180153 03/15/2018 X-spine Cortical Bone Screw System X-spine Systems, Inc. Charlene Brumbaugh
K162616 03/09/2018 Wrist Type Blood Pressure Monitor Xuzhou Yongkang Electronic Science Technology Co., Ltd YanLi Li
K173078 03/09/2018 Powder-free Clear Vinyl Patient Examination Gloves Yongsheng Medical Products Co., Ltd Jason Wei
K172500 03/01/2018 Technoweb Surgical Mask YTS GLOBAL INC. Eddie Nguyen
K180537 03/27/2018 Zavation Buttress Plate System Zavation Medical Products LLC Matt Jones
K173752 03/16/2018 SI Screw System Zavation Medical Products, LLC James M. Phillips
K172758 03/07/2018 Rotatable Snares, Non-Rotatable Snares Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long
K172762 03/20/2018 Single Use Hemoclip Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long
K180227 03/15/2018 Polaris Spinal Growth System Zimmer Biomet Spine, Inc. Anthony Michael Maahs
K173057 03/29/2018 Zimmer Knee Joint Replacement Prostheses MR Labeling Zimmer, Inc. Jason Heckaman


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